MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA CRT-D QUAD RF HV; NO MATCH

Model Number CD3365-40Q

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that patient presented in clinic for routine follow-up.Upon interrogation, it was found that patient's implantable cardioverter defibrillator (icd) was in backup mode due to event queue overflow reset.The icd was able to reset to normal setting by programming intervention.There were no patient consequences.

Event Description

New information received notes that the device was explanted and replaced.

Manufacturer Narrative

The reported event of backup operation was confirmed.The device went into backup mode due to an event queue overflow.The device was restored by reloading product code in the field.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.The cause of the event queue overflow was determined to be the integrated circuit (ic) in the radio frequency (rf) module.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Type of Device: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18536628
• MDR Text Key: 333211334
• Report Number: 2017865-2024-01434
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: 05414734508292
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: CD3365-40Q
• Device Lot Number: A000008580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATRIAL LEAD; QUARTET; RIGHT VENTRICULAR LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female